JP2024502654A - Medical dilators and systems, methods, and kits for medical dilation - Google Patents

Abstract

The medical dilator includes an elongate member having a proximal end portion, an opposing distal end portion, and a lumen extending through the elongate member from the proximal end portion to the distal end portion. There is. The dilated tip is at the distal end portion. The enlarged tip has a first end of enlarged cross-sectional area and tapers distally to a second end of reduced cross-sectional area. At least a first electrode is associated with the dilated tip. An electrical conductor is electrically connected to the first electrode and extends proximally from the first electrode toward the proximal end portion for electrical connection with the electroanatomical mapping system. .

Description

This document relates to medical dilation, such as dilation of surgically created perforations in cardiac tissue. More particularly, this document relates to medical dilators and related systems, methods, and kits.

The following summary is intended to introduce the reader to various aspects of the detailed description and is not intended to define or delineate any invention.
According to some aspects, a medical dilator includes an elongate member having a proximal end portion, an opposing distal end portion, and a lumen, the lumen extending from the proximal end portion to the distal end portion. extending through the elongated member up to the point. The dilated tip is at the distal end portion. The enlarged tip has a first end of enlarged cross-sectional area and tapers distally to a second end of reduced cross-sectional area. At least a first electrode is associated with the dilated tip. An electrical conductor is electrically connected to the first electrode and extends proximally from the first electrode toward the proximal end portion for electrical connection with the electroanatomical mapping system. .

In some examples, the first electrode is disposed between the first end of the dilated tip and the second end of the dilated tip. In some examples, the first electrode is positioned proximal to the first end of the dilated tip.

In some examples, the expanded tip has a circumferential tip surface, the circumferential tip surface has a circumferential groove defined in the circumferential tip surface, and the electrode is annular and seated within the groove. ing.
In some examples, the expanded tip has an outer tip surface, an inner tip surface, and a tip sidewall extending between the inner tip surface and the outer tip surface, and the electrical conductor extends from the electrode. It extends through the distal sidewall and into the lumen.

In some examples, the elongated member has an outer circumferential surface, an inner circumferential surface, and a sidewall extending along the length of the elongated member between the inner circumferential surface and the outer circumferential surface, and the electrical conductor is It is embedded in the sidewall and extends from the electrode to the proximal end portion. The outer circumferential surface may have a longitudinal groove defined therein and extending from the first electrode to the proximal end portion, and the electrical conductor may be seated within the longitudinal groove. Alternatively, the elongated member may include an outer tube defining an outer circumferential surface and an inner liner within the outer tube and defining an inner circumferential surface, and the electrical conductor is disposed between the outer tube and the inner liner. It may be placed in The electrical conductor may be a tubular braid.

In some examples, the first electrode is removable from the elongated member.
In some examples, the medical dilator further includes a second electrode attached to the elongated member and spaced apart from the first electrode.

In some examples, the extension tip includes a proximal piece having a distally facing shoulder surface and a neck extending distally from the shoulder surface, and the electrode is annular and received on the neck. , abuts the shoulder surface, and the extended tip further includes a distal piece received on the neck distally of the electrode and abuts the electrode.

In some examples, the first electrode forms an extended tip. The medical dilator can include a metal member having a first section and a second section, the first section can join the metal member to the elongate member, and the second section can join the metal member to the elongated member. One electrode and an extended tip can be provided.

In some examples, the electrode is radiopaque. In some examples, the electrode includes platinum-iridium.
In some examples, the electrode has an echogenic profile. In some examples, the electrode includes a coil.

According to some aspects, a kit of parts for a medical piercing system includes a medical dilator, a sheath, and a piercing device. The medical dilator has an elongate member having a proximal end portion, an opposing distal end portion, and a lumen extending through the elongate member from the proximal end portion to the distal end portion. . The medical dilator further has an expansion tip at the distal end portion, the expansion tip having an enlarged cross-sectional area first end and a reduced cross-sectional area second end. tapering distally towards the The medical dilator includes at least a first electrode associated with the dilation tip, a first electrode electrically connected to the first electrode, and a first electrode for electrical connection with an electroanatomical mapping system. and a conductor extending proximally from the electrode to the proximal end portion. The sheath is for receiving a medical dilator. A piercing device is receivable in the lumen.

In some examples, the kit of parts further includes at least a second electrode. The second electrode may be affixed to the sheath, or may be affixed to the elongated member, or may be affixed to the piercing device.

In some examples, the sheath has a tip, the medical dilator further includes a second electrode electrically connectable to the electroanatomical mapping system, and the medical dilator is completely within the sheath. When inserted into the sheath, the second electrode is proximate to the distal end of the sheath.

According to some aspects, a medical dilation system includes a medical dilator and an electroanatomical mapping system. The medical dilator includes an elongate member having a proximal end portion, an opposing distal end portion, and a lumen extending through the elongate member from the proximal end portion to the distal end portion. There is. The dilated tip is at the distal end portion. The enlarged tip has a first end of enlarged cross-sectional area and tapers distally to a second end of reduced cross-sectional area. at least a first electrode is associated with the expanded tip, and an electrical conductor is electrically connected to the first electrode and extends proximally from the first electrode to the proximal end portion. . The electroanatomical mapping system is electrically connectable to the electrical conductor and configured to receive electroanatomical mapping signals from the electrodes and to determine the position of the dilated tip based on the electroanatomical mapping signals. It is composed of

In some examples, the electroanatomical mapping system is a dielectric open source system.
According to some aspects, a method for medical expansion includes a. advancing the dilation tip of the medical dilator toward a first target anatomical location; b. receiving a first electroanatomical mapping signal from an electrode associated with the dilated tip; c. determining a first position of the dilated tip relative to the first target anatomical location based on the first electroanatomical mapping signal.

In some examples, the method includes step c. After d. The method further includes advancing a piercing device from the medical dilator and using the piercing device to form a hole at the first target anatomical location.

In some examples, the method further includes determining a location of the piercing device relative to the dilated tip.
In some examples, the method includes step d. After e. The method further includes advancing the electrode and the dilation tip through the borehole to dilate the borehole.

In some examples, the method includes step e. or after step e. During f. receiving a second electroanatomical mapping signal; g. determining a second position of the dilation tip relative to the first target anatomical location based on the second electroanatomical mapping signal. In some examples, the first target anatomical location is the atrial septum.

In some examples, the method further includes determining a position of the dilation tip relative to the left atrial wall.
In some examples, step a. the method includes positioning a dilator within the sheath, advancing the dilator and sheath toward a first target anatomical location, and the method includes the step of: determining a position of the dilation tip relative to the tip of the sheath; further including.

In some examples, the method further includes receiving a second electroanatomical mapping signal from the electrode and creating an anatomical map using the second electroanatomical mapping signal. include. The anatomical map can include at least one of a superior vena cava map, a right atrium map, and a pulmonary vein map.

The accompanying drawings are intended to be illustrative of the articles, methods, and apparatus of the present disclosure and are not intended to be limiting.
FIG. 1 is a perspective view of an exemplary surgical drilling system. 2 is a perspective view of a dilator of the surgical drilling system of FIG. 1; FIG. 3A is an enlarged view of the dilation tip of the dilator of FIG. 2; FIG. FIG. 3B is an end view of the expanded tip of FIG. 3A. FIG. 3C is a cross-sectional view taken along line 3C-3C of FIG. 3B. FIG. 4A is an enlarged view of another exemplary dilated tip. FIG. 4B is an end view of the expanded tip of FIG. 4A. FIG. 4C is a cross-sectional view taken along line 4C-4C of FIG. 4B. FIG. 5A is an enlarged view of another exemplary dilated tip. FIG. 5B is a cross-sectional view taken along line 5B-5B of FIG. 5A. FIG. 5C is an end view of the expanded tip of FIG. 5A. FIG. 5D is a cross-sectional view taken along line 5D-5D in FIG. 5C. FIG. 6A is an enlarged view of another exemplary dilated tip. FIG. 6B is an end view of the expanded tip of FIG. 6A. FIG. 6C is a cross-sectional view taken along line 6C-6C of FIG. 6B. FIG. 7 is a partial perspective view of a sheath, dilator, and piercing device of another exemplary surgical piercing system. FIG. 8 is a schematic diagram illustrating a first step of an exemplary method for forming and dilating a transseptal perforation. 9 is a schematic diagram illustrating a second step of the exemplary method for forming and dilating the transseptal perforation of FIG. 8; FIG. 10 is a schematic diagram illustrating a third step of the exemplary method for forming and dilating the transseptal perforation of FIG. 8. FIG. 11 is a schematic diagram illustrating a fourth step of the exemplary method for forming and dilating the transseptal perforation of FIG. 8. FIG. 12 is a schematic diagram illustrating a fifth step of the exemplary method for forming and dilating the transseptal perforation of FIG. 8. 13 is a schematic diagram illustrating a second step of the exemplary method for forming and dilating the transseptal perforation of FIG. 8; FIG. 14A is a partial side view of another exemplary dilator. FIG. 14B is a cross-sectional view taken along line 14B-14B of FIG. 14A. FIG. 14C is a perspective view of the metal member of the dilator of FIG. 14A.

Various devices or processes or configurations are described below to provide example embodiments of the claimed subject matter. The examples described below do not limit any claims, and any claims may encompass different processes or apparatus or configurations than those described below. The claims extend to an apparatus or process or arrangement having all of the features of any one apparatus or process or composition described below, or to a plurality or all of the apparatus or processes or compositions described below. is not limited to the characteristics of The devices or processes or compositions described below may not be embodiments of any exclusive rights conferred by publication of this patent application. Any subject matter described below and to which no exclusive rights are conferred by publication of this patent application may be the subject matter of another means of protection, e.g., a continuing patent application, and the applicant, inventor, or owner may , is not intended to disclaim, disclaim, or make available to the public any such subject matter by its disclosure in this document.

In general, disclosed herein are medical dilators (also simply referred to herein as "dilators") that can be used to dilate anatomical orifices, such as surgical perforations. For example, dilators may be used in transseptal perforation procedures, where a perforation is formed in the atrial septum of the heart, optionally using a radiofrequency perforation device, and then dilated. Expanded using devices. Such a procedure may be performed, for example, to gain access to the left atrium for treatment.

In general, the dilators disclosed herein are sensitive to the location of the dilator tip (also referred to herein as the "dilation tip") within the body or relative to other surgical instruments (e.g., relative to a piercing device). or a sheath in which the dilator is housed). More particularly, a dilator disclosed herein can include at least one electrode associated with its tip. The electrodes may be electroanatomical mapping (EAM) electrodes. The EAM electrode can be connected to an EAM system, and the EAM system can communicate EAM signals to and from the EAM electrode (directly or via a pad) based on the EAM signal received from the EAM electrode. , the position of the EAM electrode within the body or with respect to other surgical instruments, and thus the position of the dilator tip, can be determined. This allows, for example, visualization of the dilator tip to allow the user to determine whether the tip is properly positioned relative to the target tissue, and allows the perforation device to be placed within the dilator prior to perforation. and/or allow the user to confirm that the extended tip is sufficiently spaced from non-target tissue.

Referring now to FIG. 1, an exemplary surgical drilling system 100 is shown. Surgical perforation system 100 includes a dilator 102 and an EAM system 104 that includes an EAM signal generator 106 and a set (e.g., three or more) of EAM pads 108 (only two of which are shown in FIG. 1). , a sheath 110 , a radio frequency (RF) piercing device 112 having a piercing electrode 113 at its distal tip, an RF generator 114 and a grounding pad 116 . Sheath 110, RF perforation device 112, RF generator 114, and ground pad 116 are not described in detail herein and are optionally manufactured by Baylis Medical Company, Inc. (Montreal, Canada) under the trade name NRG® Transseptal Platform, or SupraCross® Transseptal Platform.

Additionally, in the alternative, another type of perforation device, such as a mechanical perforation device, may be used in place of the RF perforation device. Optionally, some or all of the components of surgical perforation system 100 may be sold or provided together as a kit, either assembled or unassembled.

Referring now to FIG. 2, dilator 102 is shown in more detail. In the illustrated example, dilator 102 is elongate and has a proximal end portion 120 that is generally directed toward a user, such as a surgeon, in use, and an opposing distal end portion 122 that is generally directed toward a target location within a patient in use. Includes member 118. Elongate member 118 extends longitudinally between proximal end portion 120 and distal end portion 122 and radially between outer circumferential surface 126 and inner circumferential surface 128 (shown in FIGS. 3B and 3C). Includes an extending sidewall 124. Inner circumferential surface 128 defines a lumen 130 (shown in FIGS. 3B and 3C) that extends through elongated member 118 from proximal end portion 120 to distal end portion 122. In use, lumen 130 can receive RF piercing device 112.

The elongated member may be made from a variety of materials including, but not limited to, plastics such as high density polyethylene (HDPE).
Still referring to FIG. 2, in the example shown, a handle 132 is attached to the proximal end portion 120. Handle 132 may include various hubs and/or ports and/or connection points (not shown) for connecting to various external devices.

Still referring to FIG. 2, dilator 102 includes an expansion tip 134 at distal end portion 122. Dilated tip 134 is shown in more detail in FIGS. 3A-3C.
All or a portion of dilated tip 134 may be integrated with elongated member 118. That is, the distal end portion 122 of the elongated member 118 may include an enlarged tip 134, as shown in FIGS. 3A-3C. Alternatively, the dilated tip 134 may be a separate part from the elongated member 118 and joined to the distal end portion 122 of the elongated member 118, as described below with respect to FIGS. 14A-14C. Good too.

In the illustrated example, dilated tip 134 includes a first end 136 and a second end 138 spaced distally from first end 136 . The enlarged tip 134 tapers in cross-sectional area from the first end 136 to the second end 138 such that the first end 136 is narrower than the second end 138. The second end 138 has an enlarged cross-sectional area relative to the first end 136 . When the expanded tip 134 passes through the opening, the opening expands due to the enlargement of the cross-sectional area.

In the illustrated example, second end 138 of dilation tip 134 forms distal end 140 of dilator 102 . In an alternative (not shown), the dilation tip may be spaced proximally from the distal end of the dilator.

With further reference to FIGS. 3A-3C, in the illustrated example, the dilated tip 134 has a sidewall 142 (also referred to herein as a “tip sidewall”), and the sidewall 142 is a first extends longitudinally between an end 136 of the extended tip 134 and a second end 138 of the expanded tip 134, and extends longitudinally between an outer peripheral surface 144 of the expanded tip 134 (also referred to herein as a "distal peripheral surface") and a second end 138 of the expanded tip 134. It extends radially between an inner circumferential surface 146 (also referred to herein as a "tip inner circumferential surface") of the distal end portion 134 . Distal sidewall 142, outer distal circumferential surface 144, and inner distal circumferential surface 146 form a portion of sidewall 124 of elongated member 118, outer circumferential surface 126 of elongated member 118, and inner circumferential surface 128 of elongated member 118, respectively.

With further reference to FIGS. 3A-3C, the dilator further includes an EAM electrode 148 associated with the dilation tip 134. As discussed above, the EAM electrode 148 can determine the position of the dilated tip 134, such as the position of the dilated tip 134 within the body or relative to other portions of the surgical drilling system 100. It can be done. EAM electrode 148 may be, for example, annular and may be formed of or include stainless steel or platinum-iridium. In some examples, the EAM electrode may be additionally radiopaque, which may allow visualization of the electrode using fluoroscopy, if desired. In a further example, the EAM electrode may optionally have an echogenic profile that may allow visualization of the electrode using ultrasound. For example, an EAM electrode may include a coil. In some examples, EAM electrode 148 can be made of conductive paint.

As mentioned above, EAM electrode 148 is associated with dilated tip 134. The term "associated" can be used either directly (e.g., when the EAM electrode 148 forms all or a portion of the extended tip, or when the EAM electrode is attached directly to the extended tip 134) or indirectly (e.g., when the EAM electrode 148 forms all or a portion of the extended tip 134) For example, if EAM electrode 148 is spaced apart from dilated tip 134 and extrapolation is performed to determine the position of dilated tip 134 based on the position of EAM electrode 148), the position of dilated tip 134 The EAM electrodes 148 are shown positioned to allow determination of .

In the illustrated example, the EAM electrode 148 is annular and extends circumferentially around the dilated tip 134 and between the first end 136 of the dilated tip 134 and the second end of the dilated tip 134. 138. In the alternative (eg, as shown in FIGS. 5A-5D), the EAM electrode may be placed proximal to the dilated tip or distal to the dilated tip. In such an example, extrapolation may be performed to determine the position of the dilation tip based on the position of the EAM electrode, as described above.

Referring to FIG. 3C, in the example shown, the outer circumferential surface 144 of the dilated tip 134 has a circumferential groove 150 defined therein, and the EAM electrode 148 is seated within the groove 150. EAM electrode 148 may be secured within groove 150 in a variety of ways, such as gluing, welding, soldering, and/or friction. Additionally, in the example shown, the EAM electrode 148 has a profile that matches the taper of the dilated tip 134 such that the outer surface of the EAM electrode 148 is flush with the circumferential surface 144 of the dilated tip 134. be. This can be achieved, for example, by swaging. This may allow for a smooth transition as the dilated tip 134 passes through the opening.

In the illustrated example, the dilated tip 134 is of unitary construction. In an alternative example, the dilated tip may be of multi-piece construction, as described below with reference to FIGS. 4A-4C.
3A-3C, an electrical conductor 152 is connected to the EAM electrode 148 and is connected to the EAM signal generator 106 of the EAM system 104 (not shown in FIGS. 3A-3C). Extending proximally from electrode 148 toward proximal end portion 120 of elongate member 118 (not shown in FIGS. 3A-3C). Electrical conductor 152 is electrically isolated between EAM electrode 148 and its connection to EAM signal generator 106 such that electrical signals are communicated between EAM electrode 148 and EAM system 104. can be done. For example, conductor 152 may include a polyimide insulating layer.

The end of the electrical conductor 152 that is connected to the EAM electrode 148 may be referred to herein as the "electrode end portion 154" (shown in FIG. 3C) of the electrical conductor 152, and may be referred to herein as the "electrode end portion 154" (shown in FIG. 3C) of the electrical conductor that is connectable to the EAM system 104. The end of 152 may be referred to herein as a "system end portion 156" (shown in FIGS. 1 and 2) of electrical conductor 152. System end portion 156 of electrical conductor 152 may be connected or connectable to EAM signal generator 106 in a variety of ways. In the illustrated example, a connector 158 is attached to the system end portion 156. Connector 158 is matable with connector 160 of EAM signal generator 106 . Alternatively, clips (eg, alligator clips) may be used to connect the system end portions of the electrical conductors to the EAM system (not shown).

With further reference to FIGS. 3A-3C, in the illustrated example, electrical conductor 152 extends from EAM electrode 148 through distal sidewall 142 and into lumen 130. Electrical conductor 152 then extends through lumen 130 to proximal end portion 120 of elongated member 118. In the alternative, the electrical conductors may be embedded within the sidewalls of the elongate member, as described below.

As mentioned above, in the illustrated example, EAM system 104 includes an EAM signal generator 106 and a pair of EAM pads 108. Such systems are commercially available, for example, under the brand names ENSITE PRECISION(TM) and CARTO(R), and will not be described in detail herein. Briefly, electrical signals are transferred from the EAM signal generator 106 to the EAM pad 108, from the EAM pad 108 to the EAM electrode 148, and from the EAM electrode 148 back to the EAM signal generator 106 (or in the reverse order, i.e., the EAM signal generator 106 to EAM electrode 148, EAM electrode 148 to EAM pad 108, and EAM pad 108 back to EAM signal generator 106), the EAM electrode 148 can be visualized and thus The location can be determined. In some examples, EAM system 104 may be a dielectric open source EAM system (eg, one available under the brand name KODEX-EPD). In addition to allowing for the determination of the position of the dilator's expansion tip, such a system allows the dilator to be positioned within the anatomy without necessarily contacting cardiac tissue, as described in further detail below. can be used for target mapping (e.g., to map the geometry of heart chambers).

In the illustrated example, drilling electrode 113 of RF drilling device 112 may also be used as an additional EAM electrode. That is, the piercing electrode 113 of the RF piercing device 112, along with the EAM electrode 148 of the dilator 102, may be electrically connected to the EAM system 104 and its position can be determined by the EAM system 104.

Referring now to FIGS. 4A-4C, an alternative example of an expanded tip is shown. In FIG. 4, features similar to those in FIGS. 1-3 are referenced with similar reference numerals, plus 300. The dilated tip 434 of FIG. 4 is similar to the dilated tip 134 of FIGS. 1-3, but the dilated tip 434 is of multi-piece construction. Specifically, in the illustrated example, dilated tip 434 includes a proximal piece 462 and a distal piece 464. Proximal piece 462 is stepped to define a distally facing shoulder surface 466 and has a neck 468 extending distally from shoulder surface 466 . EAM electrode 448 is annular and is received on neck 468 and abuts shoulder surface 466. A distal piece 464 is received on and abuts the neck 468 distally of the EAM electrode 448 . Proximal piece 462, EAM electrode 448, and distal piece 464 may be secured to each other in a variety of ways, such as adhesively and/or frictionally.

Referring now to FIGS. 5A-5D, another alternative example of an expanded tip is shown. In FIG. 5, features similar to those in FIGS. 1-3 are referenced with similar reference numerals, plus 400. The expanded tip 534 of FIG. 5 is similar to the expanded tip 134 of FIGS. 1-3, but the electrical conductor 552 is embedded in the sidewall 524 of the elongated member 518. Specifically, the outer peripheral surface 526 of the elongate member 518 has a longitudinal groove 570 defined therein. Groove 570 extends from EAM electrode 548 to a proximal end portion (not shown) of elongate member 518. Electrical conductor 552 is seated within groove 570, and a strip of material 572 (eg, plastic or adhesive) fills groove 570 over electrical conductor 552.

Referring now to FIGS. 6A-6C, another alternative example of an expanded tip is shown. In FIG. 6, features similar to those in FIGS. 1-3 are referenced with similar reference numerals, plus 500. The dilation tip 634 of FIG. 6 is similar to the dilator of FIGS. 1-3, except that the elongated member 618 includes an outer tube 674 defining an outer circumferential surface 626 and an outer tube 674 defining an inner circumferential surface 628. and an inner liner 676 inside. Inner liner 676 may be, for example, a polyimide or polytetrafluoroethylene liner, and outer tube 674 may be formed of a plastic such as HDPE.

In the example of FIG. 6, electrical conductor 652 is defined by a tubular braid of metal wire disposed between outer tube 674 and inner liner 676. In the example of FIG.
Optionally, to manufacture the dilator of FIG. , an electrical connection can be formed between the EAM electrode 648 and the electrical conductor 652. The material of outer tube 674 can then be reflowed (eg, by applying heat) to join outer tube 674, electrical conductor 652, and inner liner 676. Distal piece 664 of dilated tip 634 may then be joined to the assembly. A system end (not shown) of electrical conductor 652 may then be exposed for connection to EAM system 104, optionally by skiving.

Referring now to FIG. 7, another example of a surgical drilling system is shown. In FIG. 7, features similar to those in FIG. 1 are referenced with similar reference numerals, plus 600. In FIG. 7, only the dilator 702, sheath 710, and RF piercing device 712 of the system 700 are shown; the remaining portions of the system 700 may be the same or similar to those shown in FIG. System 700 of FIG. 7 includes additional EAM electrodes. Specifically, system 700 includes a first EAM electrode 748a associated with an expanded tip, as described above with respect to FIGS. 1-3. Additionally, the system includes a second EAM electrode 748b on the dilator 702 and spaced from the first EAM electrode 748a, a third EAM electrode 748c on the sheath 710, a fourth EAM electrode 748d, and A fifth EAM electrode 748e and a sixth EAM electrode 748f on the RF drilling device 712 are included. The second through sixth EAM electrodes (748b-748f) are connectable to an EAM signal generator via additional electrical conductors (not shown). The use of additional EAM electrodes may allow additional position data to be determined. For example, the position of sheath 710 or the position of dilated tip 734 relative to sheath 710 can be determined. Additionally, additional electrodes may be provided to determine the orientation of the sheath or dilator. For example, providing at least two electrodes on each of the sheath and dilator allows determination of the direction in which the device is oriented.

In another example (not shown), the dilator may be similar to dilator 702 of FIG. 7, but the second EAM electrode is The two EAM electrodes may be positioned proximate (eg, flush or near flush with the tip of the sheath). In such instances, even if the sheath itself does not contain any EAM electrodes, the second EAM electrode of the dilator may be used to detect the tip of the sheath when the dilator is fully inserted within the sheath. position can be determined. For example, the second EAM electrode of the dilator can be used to determine whether the sheath tip has entered the left atrium during a transseptal puncture procedure.

Referring now to FIGS. 14A-14C, another example of a dilator is shown. In FIGS. 14A-14C, features similar to those in FIGS. 1-3 are referenced with similar reference numerals, plus 1300. In dilator 1402, dilation tip 1434 is similar to dilation tip 134 of FIGS. 1-3, but an EAM electrode 1448 forms dilation tip 1434. That is, a metal member 1458 (shown separately in FIG. 14C) is provided that includes a first section 1460 and a second section 1462. First section 1460 secures metal member 1458 to elongate member 1418 and second section 1462 functions as EAM electrode 1448 and also forms expanded tip 1434. First section 1460 includes a rib 1464 embedded in elongate member 1418 to secure metal member 1458 to elongate member 1418. A second section 1462 extends distally from the first section 1460 and tapers in cross-sectional area from its first end 1436 to its second end 1438 and includes an enlarged tip 1434. is formed. In this example, EAM electrode 1448 forms the distal end 1440 of dilator 1402, thus allowing tissue contact with the EAM electrode.

In a further alternative dilator (not shown), the EAM electrode may be removable from the elongate member. For example, the elongate member of the dilator may be a standard dilator (eg, as known in the art). The EAM electrode connected to the electrical conductor may be separate from the elongate member. For example, an EAM electrode can be secured to a drilling device. The EAM electrode can be advanced through the lumen of the elongated member until the EAM electrode reaches the distal end of the dilator. The assembly can be calibrated so that it knows how far to advance the EAM electrode to reach the distal end.

Referring now to FIGS. 8-13, a method for medical dilation, and specifically for the formation and dilation of a transseptal perforation, will now be described. As described in more detail, at various points in the method, the EAM electrode and EAM system can be activated to determine the position of the dilator tip. That is, EAM signals are received from EAM electrodes of the dilator, and based on the EAM signals, the position of the dilation tip of the dilator can be determined and optionally mapped and tracked. This can increase the safety of the treatment. Although the method is described with reference to the system 100 and dilator 102 shown in FIGS. 1-3, the method is not limited to being performed with the system 100 and dilator 102, and 100 and dilator 102 are not limited to use in the manner described.

Referring to FIG. 8, a guidewire 800 may be advanced toward the heart 802 via the femoral vein and "placed" within the superior vena cava (SVC) 804.
Referring to FIG. 9, with dilator 102 within sheath 110 and dilation tip 134 extending beyond sheath 110, dilator 102 and sheath 110 are advanced over guidewire 800 toward SVC 804. It's okay to let me do it. The guidewire 800 can then be removed and the RF piercing device 112 (not shown in FIG. 9) is inserted so that the piercing electrode 113 (not shown in FIG. 9) of the RF piercing device 112 is distal to the dilator 102. The dilator 102 can be advanced until it is in close proximity to the distal end 140.

As discussed above, in addition to the EAM electrode 148 of the dilator 102 being connected to the EAM system 104 (not shown in FIGS. 8-13), the piercing electrode 113 of the RF piercing device 112 is connected to the EAM system 104. and can function as an additional EAM electrode. The RF piercing device 112 is advanced through the dilator 102 and the piercing electrode 113 is exposed from the dilator 102 or the distal tip of the piercing device 112 is flush with the distal tip of the dilator 102. Thereafter, the placement of drilling device 112 may be confirmed using EAM system 104. Specifically, EAM system 104 may be activated to determine the position of piercing electrode 113 relative to dilated tip 134 based on EAM signals received from EAM electrode 148 and piercing electrode 113. For example, if the EAM system indicates that the piercing electrode 113 is protruding from the dilation tip 134, it may be determined that the piercing electrode 113 has been advanced too deeply into the dilator 102. Alternatively, if the drilling electrode 113 cannot be detected by the EAM system, it can be concluded that the drilling electrode 113 is covered within the dilated tip 134 and is therefore correctly positioned. Additionally, by providing both the drilling electrode 113 and the EAM electrode 148, the relative positioning between the two can be mapped to allow the orientation of the combined assembly to be determined.

In some examples, system 100 may be further configured to provide an alert if piercing electrode 113 is advanced distal to distal end 140 of dilator 102.
Optionally, at this point, the user can refer to CT or MRI data if anatomical data is desired.

Referring now to FIG. 10, the sheath 110, the expanded Instrument 102 and piercing device 112 may be advanced toward the target anatomical location to position dilated tip 134 at the target location. The target anatomical location may be, for example, the fossa ovalis 806 of the atrial septum 808. EAM electrode 148 and EAM system 104 may be used to confirm the placement of dilation tip 134 relative to fossa ovalis 806, ensuring that piercing electrode 113 is flush with distal end 140 of dilator 102. You can also.

Referring to FIG. 11, perforation device 112 can then be activated and advanced from dilator 102 to form a perforation in atrial septum 808.
Referring to FIG. 12, dilation tip 134 may then be advanced through the borehole to dilate the borehole. Specifically, the dilated tip 134 can be advanced through the borehole along with the EAM electrode 148. EAM electrode 148 and EAM system 104 may be actuated to determine the position of dilated tip 134 prior to, during, and/or after advancement of dilated tip 134 and EAM electrode 148. This may help ensure that the borehole is sufficiently expanded, while also ensuring that the expansion tip 134 does not contact and thereby damage non-target tissue. may also be helpful (e.g., can visualize the position of the dilation tip relative to the left atrial wall).

Following dilation of the perforation, various procedures can be performed. At a desired time, dilator 102 and sheath 110 can be withdrawn from heart 802, as shown in FIG. 13. Optionally, during withdrawal, EAM electrode 148 and EAM system 104 may be activated to determine the position of dilated tip 134.

Optionally, anatomical mapping can be performed using dilator 1402 and EAM system 104 throughout the method. That is, as discussed above, if EAM system 104 is a dielectric open source EAM system, dilator 102 and EAM system 104 can be used for cardiac mapping without necessarily contacting cardiac tissue. For example, during advancement of dilator 102, EAM system 104 may be activated (i.e., electroanatomical signals may be received from EAM electrodes 148) to map SVC 804 when dilator 102 is in the inferior vena cava. be able to. As a further example, EAM system 104 may be activated to map right atrium 808 when dilator 102 is within right atrium 808. As a further example, after the dilator 102 traverses the atrial septum 808, the EAM system 104 can be activated to map the pulmonary veins. This can be facilitated by rotating dilator 102. In such instances, more detail and higher resolution may be achieved as dilator 102 advances toward the location to be mapped. Additionally, in instances where the EAM electrode is at the distal end of the dilator, the EAM system may be capable of providing an alert if tissue is contacted by the distal end of the dilator.

Although the above description provides examples of one or more processes or devices or configurations, it will be understood that other processes or devices or configurations may be within the scope of the following claims.

Any modifications, characterizations, or other claims previously made (in this application or in any related patent application or patent, including any parent, sibling, or child) with respect to the prior art or other art; To the extent that any subject matter disclaimer may be construed as a disclaimer of any subject matter supported by the disclosure of this application, Applicants hereby cancel and revoke such disclaimer. Applicants also respectfully note that it may be necessary to review any prior art previously discussed in any related patent applications or patents, including any parents, siblings, or children.

Claims (36)

A medical dilator,
an elongate member having a proximal end portion, an opposing distal end portion, and a lumen, the lumen extending through the elongate member from the proximal end portion to the distal end portion; parts and
an enlarged tip at the distal end portion having a first end of enlarged cross-sectional area and tapering distally to a second end of reduced cross-sectional area; with an expanded tip,
at least a first electrode associated with the expanded tip;
an electrical conductor electrically connected to the first electrode and extending proximally from the first electrode toward the proximal end portion for electrical connection with an electroanatomical mapping system; A medical dilator equipped with. The medical dilator of claim 1, wherein the first electrode is disposed between the first end of the dilation tip and the second end of the dilation tip. . The medical dilator of claim 1, wherein the first electrode is located proximal to the first end of the dilation tip. The expanded tip has an outer circumferential tip surface, the outer circumferential tip surface has a circumferential groove defined in the outer circumferential tip surface, and the electrode is annular and seated within the groove. The medical dilator according to any one of claims 1 to 3, wherein: The medical dilator according to claim 4, wherein the electrode has an outer electrode surface, and the electrode outer surface is flush with the outer peripheral surface of the distal end. The expanded tip portion has a tip outer circumferential surface, a tip inner circumferential surface, and a tip side wall extending between the tip inner circumferential surface and the tip outer circumferential surface; A medical dilator according to any preceding claim, extending into the lumen through a distal sidewall. The elongated member has an outer circumferential surface, an inner circumferential surface, and a sidewall extending along the length of the elongated member between the inner circumferential surface and the outer circumferential surface; A medical dilator according to any preceding claim, embedded in a sidewall and extending from the electrode to the proximal end portion. The outer circumferential surface has a longitudinal groove defined therein and extending from the first electrode to the proximal end portion, and the electrical conductor is seated within the longitudinal groove. 8. The medical dilator according to claim 7. The elongate member includes an outer tube defining the outer circumferential surface and an inner liner within the outer tube and defining the inner circumferential surface, and the electrical conductor is arranged between the outer tube and the inner liner. 8. The medical dilator of claim 7, wherein the medical dilator is located in a. 10. The medical dilator of claim 9, wherein the electrical conductor is a tubular braid. A medical dilator according to any preceding claim, wherein the first electrode is removable from the elongate member. The medical dilator of any preceding claim, further comprising a second electrode attached to the elongate member and spaced from the first electrode. the expanded tip includes a proximal piece having a distally facing shoulder surface and a neck extending distally from the shoulder surface;
the electrode is annular and received on the neck and abuts the shoulder surface;
2. The medical dilator of claim 1, wherein the dilation tip further includes a distal piece received on the neck distally of the electrode and abutting the electrode. The medical dilator of claim 1, wherein the first electrode forms the dilation tip. further comprising a metal member having a first section and a second section, the first section joining the metal member to the elongate member, and the second section joining the first electrode and the extension 15. The medical dilator of claim 14, wherein the medical dilator provides a tip. A medical dilator according to any one of claims 1 to 15, wherein the electrode is radiopaque. A medical dilator according to any preceding claim, wherein the electrode comprises platinum-iridium. A medical dilator according to any preceding claim, wherein the electrode has an echogenic profile. 19. The medical dilator of claim 18, wherein the electrode includes a coil. A parts kit for a medical perforation system, comprising:
A medical dilator comprising: an elongate member having a proximal end portion, an opposing distal end portion, and a lumen, the lumen extending from the proximal end portion to the distal end portion of the elongate member; an elongated member extending therethrough and an enlarged tip at the distal end portion having a first end of enlarged cross-sectional area and a second end of reduced cross-sectional area; an enlarged tip tapering distally toward the region; at least a first electrode associated with the enlarged tip; and electrically connected to the first electrode; an electrical conductor extending proximally from the first electrode to the proximal end portion for electrical connection with a medical mapping system;
a sheath for receiving the medical dilator;
a piercing device receivable in the lumen; and a kit of parts. 21. The kit of parts of claim 20, further comprising at least a second electrode, the second electrode being secured to the sheath. 21. The kit of parts of claim 20, further comprising at least a second electrode, the second electrode being secured to the elongate member. 21. The kit of parts of claim 20, further comprising at least a second electrode, the second electrode being secured to the drilling device. The sheath has a tip,
The medical dilator further comprises a second electrode electrically connectable to the electroanatomical mapping system;
21. The kit of parts of claim 20, wherein the second electrode is proximate the distal end of the sheath when the medical dilator is fully inserted within the sheath. A medical expansion system,
A medical dilator comprising: an elongate member having a proximal end portion, an opposing distal end portion, and a lumen, the lumen extending from the proximal end portion to the distal end portion of the elongate member; an elongated member extending therethrough and an enlarged tip at the distal end portion having a first end of enlarged cross-sectional area and a second end of reduced cross-sectional area; an enlarged tip tapering distally toward the tip; at least a first electrode associated with the enlarged tip; and electrically connected to the first electrode; an electrical conductor extending proximally from one electrode to the proximal end portion;
electrically connectable to the electrical conductor and configured to receive an electroanatomical mapping signal from the electrode and determine a position of the dilated tip based on the electroanatomical mapping signal. A medical expansion system comprising an electroanatomical mapping system. 26. The medical dilation system of claim 25, wherein the electroanatomical mapping system is a dielectric open source system. A method for medical expansion, the method comprising:
a. advancing an expansion tip of the medical dilator toward a first target anatomical location;
b. receiving a first electroanatomical mapping signal from an electrode associated with the expanded tip;
c. determining a first position of the dilated tip relative to the first target anatomical location based on the first electroanatomical mapping signal. Step c. After d. 28. The method of claim 27, further comprising advancing a perforation device from the medical dilator and using the perforation device to form a perforation at the first target anatomical location. 29. The method of claim 27 or 28, further comprising determining the position of the piercing device relative to the dilated tip. Step d. After e. 30. The method of any one of claims 27-29, further comprising advancing the electrode and the expansion tip through the perforation to dilate the perforation. Step e. or after step e. During f. receiving a second electroanatomical mapping signal; g. 31. The method of claim 30, further comprising determining a second position of the dilated tip relative to the first target anatomical location based on the second electroanatomical mapping signal. 32. The method of any one of claims 27-31, wherein the first target anatomical location is the atrial septum. 33. The method of any one of claims 27-32, further comprising determining the position of the dilation tip relative to the left atrial wall. Step a. the method includes disposing the dilator within a sheath, advancing the dilator and the sheath toward the first target anatomical location, the method comprising: disposing the dilator within a sheath; 34. A method according to any one of claims 27 to 33, further comprising the step of determining the position of the part. Claims 27-34, further comprising receiving a second electroanatomical mapping signal from the electrode and creating an anatomical map using the second electroanatomical mapping signal. The method described in any one of the above. 36. The method of claim 35, wherein the anatomical map includes at least one of a superior vena cava map, a right atrium map, and a pulmonary vein map.

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